Dimethindene oral drops 1mg/ml, 20ml

Composition

Per 1 ml:

Active ingredient:  

Dimethindenee maleate – 1,0 mg.

Auxiliary substances:  

sodium hydrophosphate dodecahydrate-16.0 mg,

citric acid monohydrate-5.0 mg,

benzoic acid-1.0 mg,

disodium edetate-1.0 mg,

sodium saccharinate-0.5 mg,

propylene glycol-100.0 mg,

purified water-up to 1 ml

Pharmacological action

Antihistamine, anti-allergic and antipruritic agent. H1-histamine receptor blocker, is a competitive histamine antagonist.

The drug reduces the increased capillary permeability associated with allergic reactions.

It also has an anti-radikinin and weak m-holinoblokiruyushchy effect. When taking the drug during the day, there may be a slight sedative effect.

Pharmacokinetics:

It is rapidly and fairly fully absorbed when taken orally. Bioavailability is about 70%. The antihistamine effect begins to manifest itself 30 minutes after ingestion, reaching its maximum severity after 5 hours. The time to reach the maximum concentration of Dimethindenee in blood plasma after oral use is 2 hours. Plasma protein binding is 90%. Penetrates well into tissues.

It is metabolized in the liver by hydroxylation and methoxylation. The elimination half-life is 6 hours. It is excreted in the bile and urine (90% as a metabolite and 10% unchanged).

Indications

Allergic diseases: urticaria, hay fever, year-round allergic rhinitis, angioedema; food and drug allergies.

Skin pruritus of various origins (eczema, pruritic dermatoses: including atopic dermatitis; measles, rubella, chickenpox, insect bites).

Prevention of allergic reactions during hyposensitizing therapy.

Use during pregnancy and lactation

The use of the drug during pregnancy (II-III trimester) is possible under the supervision of a doctor, only if the expected benefit to the mother exceeds the potential risk to the fetus.

The use of the drug during breastfeeding is contraindicated.

Contraindications

Hypersensitivity to Dimethindenee and other components of the drug that are part of the drug, angle-closure glaucoma, bronchial asthma, prostatic hyperplasia, children under 1 month of age, pregnancy I trimester, breastfeeding.

With caution:

For chronic obstructive pulmonary diseases, epilepsy.

In children aged from 1 month to 1 year, since sedation can be accompanied by episodes of nocturnal apnea.

Side effects

The frequency of adverse reactions that may occur during therapy is given in the following gradation: very common (≥ 3/10); common (≥ 1/100 to <1/10); infrequent (≥ 1/1000 to <1/100); rare (≥ 1/10000 to <1/1000); very rare (

Immune system disorders:

Very rare: anaphylactoid reactions, including facial edema, pharyngeal edema, rash, muscle spasms, and shortness of breath.

Mental disorders:

Rare: anxiety.

Nervous system disorders:

Very often: fatigue;

Often: drowsiness, nervousness;

Rarely: headache, dizziness.

Disorders of the gastrointestinal tract:

Rare: gastrointestinal disorders, nausea, dry mouth, dry larynx.

If any of the side effects listed in the instructions get worse or you notice any other side effects that are not listed in the instructions, tell your doctor.

Interaction

Increases the effect of anxiolytics, sleeping pills and other drugs that inhibit the function of the central nervous system (opioid analgesics, anticonvulsants, tricyclic antidepressants, MAO inhibitors, antihistamines, antiemetics, neuroleptics, scopolamine, ethanol).

Tricyclic antidepressants and m-holinoblockers (bronchodilators, gastrointestinal antispasmodics, etc. ) increase the risk of increased intraocular pressure or urinary retention.

It is also necessary to avoid the combined use of antihistamines and procarbazine.

How to take, course of use and dosage

Inside.

Children aged 1 month to 12 years:  The recommended daily dose is 0.1 mg / kg of body weight, which is equivalent to 2 drops per kg of body weight. The daily dose should be divided into 3 doses.

Children aged from 1 month to 1 year should take the drug only as prescribed by a doctor and if there are indications for the use of H1-histamine receptor blockers.

Children over 12 years of age and adults:  the recommended daily dose is 3-6 mg of Dimethindenee (60-120 drops), divided into 3 doses, that is,20-40 drops 3 times a day.

20 drops = 1 ml = 1 mg of Dimethindenee.

For elderly patients (over 65 years of age) no dose adjustment is required.

For patients who are prone to drowsiness, it is recommended to apply 40 drops before bedtime and 20 drops in the morning.

Overdose

Symptoms: depression of the Central nervous system (CNS) and drowsiness (mostly in adults), stimulation of the Central nervous system and m-holinoblokiruyuschee effects (especially in children), including agitation, ataxia, tachycardia, hallucinations, tonic-clonic convulsions, mydriasis, dry mouth, “tides” of blood to the face, urinary retention and fever; decrease in blood pressure, collapse.

Treatment:  activated charcoal, saline laxatives, medications to support the activity of the cardiovascular and respiratory systems (analeptic medications should not be used).

Special instructions

In young children, especially under 6 years of age, antihistamines can cause increased excitability.

The drug should not be exposed to high temperatures; when prescribed to infants, they should be added to a bottle of warm baby food immediately before feeding. If the child is already being spoon-fed, drops can be given undiluted. Drops have a pleasant taste.

Do not exceed the recommended dose.

It is ineffective for itching associated with cholestasis.

Influence on the ability to drive vehicles and mechanisms:

Like other antihistamines, Dimethindenee can weaken attention, so it should be taken with caution when driving a car, working with mechanisms, or in other types of work where increased attention is required.

Form of production

By 10,20,30,40,50,60,70,80,90,100 ml of the drug in a dark glass bottle equipped with a dropper made of low-density polyethylene and a polypropylene cap or polyethylene cap.

Each bottle is marked with a label made of writing paper or label paper or a self-adhesive label.

Each bottle together with the instructions for use is placed in a pack of boxed cardboard for consumer packaging or chrome-ersatz cardboard.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Dimethindenee

Dosage form

oral drops